Accelerated Aging Techniques for Medical Device Packaging - Recorded Webinar

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Karl R. Leinsing

Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.

AA is used to estimate the useful lifespan of a product or its shelf life when actual lifespan data is unavailable. The ability of product designers to accurately predict changes in polymer properties is of critical importance to the medical device, consumer, and industrial markets.

Join this Webinar to better understand and start taking advantage of accepted Accelerated Aging Techniques. Understand General Aging Theory - The Simplified Protocol for Accelerated Aging (10 Degree Rule) and Iterative Test Designs.

In order to design a test plan that accurately models the time correlated degradation of polymers, it is necessary to have an in-depth knowledge of materials composition and structure, end product use and mis-use, assembly and sterilization process effects. Basic polymer chemistry will be reviewed as well as the changes in polymer characteristics that can be anticipated and designed for. Learn how to plan for post-production and lifetime functionality.

Why should you Attend: Accurate prediction of product shelf-life performance is critical to your success. "Do it right the first time", choose the most functional and resistant materials for your product instead of going through the post launch cycle of panic driven product revisions. Also learn the basis for choosing the optimum accelerated test design based on materials, product design, processing, and functional product requirements. Learn how to "think like a molecule" and plan and design around "aging" induced changes in materials qualities (brittleness, color, and odor) that cut short your product's long term functionality. The understanding of a product's long term safety and efficacy is a must in today's litigious world.

Learn how to:
- Understand the design and use of accelerated aging programs to shorten development time
- Identify the materials that perform best in "stressful" environments
- Effects of processing (molding, assembly)
- Enhance product and packaging designs
- Product Design features to avoids

Areas Covered in the Session:
- Shelf Life Test Methods - Accelerated Aging Test Design - Modeling
- General Aging Theory - Simplified Protocol
- Accelerated Aging Test Designs
- Polymers Chemistry - choosing the best polymer candidate
- Product Validation and Verification (ISO9001)
- Regulatory (i.e. FDA, ISO) Acceptance and Legal Considerations
- FDA Guidance
- Determining Useful Product Life - from Consumer or medical Products to Atomic Reactors
- What time periods and what accelerated stresses to target
- History
- Reaction Rate Coefficient, Zero and First Order, Q10 = 2; Arrhenius function
- Enhanced Test Designs i.e. Iterative Test Design
- Materials Guidances - AAMI TIR # 17, ASTM
- Product design - Features to Avoid
- The influences of product assembly (molding, automation, etc.)'
- Material selection
- Packaging Design and Materials
- Quantitative vs Qualitative Test Attributes - Statistical Analysis
- Environmental test Limits
- Worst Case Testing - Achilles Heel
- "Ambient" or actual product storage and use conditions
- Significance in Differences in Coefficients of Expansion
- Commonly used stressors - Temperature, Irradiation, Chemicals, Humidity
- Stress Cycling
- Effects of Humidity on common polymers, packaging
- Effects of sterilization modality (Medical Disposables)
- Interim test Intervals
- Test Sample Size Plans and Control Groups
- Results - Conservative, Unrealistic Outcomes
- Critical Temperatures of Plastic Materials - Tg, Tm, To

Who Will Benefit:
- Product Design Engineers
- Quality Management and Engineers
- Regulatory Affairs
- Project Managers
- Staff evaluating risk, safety, and effectiveness
- R&D Staff - engineering and lab personnel
- Process Engineers
- Packaging Engineers
- Materials Engineers
- Manufacturing Engineers
- Liability - Lawyers, Paralegals

Karl R. Leinsing has experience with design and project management since 1988 and has been in the Medical Product Device Design and Development industry since 1992. His areas of expertise include full life cycle product development, product conception, polymer selection, thorough computer-aided product design, dynamic mechanical analysis and root cause analysis, molding and manufacturing, project organization, technical presentations and leadership, and cross-functional teamwork. Karl currently holds 19 patents (several patents pending), 5 design awards, was listed as one of "100 notable people in the Medical Device Industry" by Medical Device and Diagnostic Industry (MDDI), and was inducted into the Product Design & Development Engineer Hall of Fame.

Karl has a Masters of Science Degree in Mechanical Engineering from North Carolina A&T State University and a Bachelor of Science Degree in Mechanical Engineering from the University of New Hampshire. He is a licensed professional engineer in New Hampshire and has lectured Medical Device and Manufacturing (MD&M) Seminars on The Science of Successful Product Design. Karl Leinsing serves on Eureka Medical's Board of Advisors and reviews and evaluates new medical product ideas for this company along with its other distinguished members. He also serves on the Inventor's Workshop Board of Directors to review new products for the promotional and retail industry.

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